Lupin has announced the launch of Raltegravir Tablets USP, 600 mg in the United States, following approval from the U.S. FDA. This product is a bioequivalent to Merck Sharp & Dohme’s Isentress® HD Tablets, 600 mg and is used for HIV-1 treatment. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity. The estimated annual sale of the reference drug in the U.S. was USD 26 million as of September 2026.
Lupin Launches Raltegravir Tablets USP in the US
Lupin Limited has officially announced the launch of Raltegravir Tablets USP, 600 mg in the United States. This development follows the U.S. Food and Drug Administration’s (FDA) approval of Lupin’s Abbreviated New Drug Application (ANDA).
First-to-File Status and Exclusivity
The company highlighted that it is the exclusive first-to-file for this product, which makes it eligible for a 180-day generic drug exclusivity. Raltegravir Tablets, 600 mg are bioequivalent to the reference listed drug (RLD) Isentress® HD Tablets, 600 mg, manufactured by Merck Sharp & Dohme, LLC.
Therapeutic Indication and Market Potential
These tablets are indicated for the treatment of Human Immunodeficiency Virus (HIV-1) infection in adults and pediatric patients weighing at least 40 kg, when used in combination with other antiretroviral agents. The estimated annual sales for the reference drug, Isentress® HD, in the U.S. market were approximately USD 26 million for the period ending September 2026, according to IQVIA data.
About Lupin Limited
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a significant presence across India, the U.S., and other international markets. The company offers a diversified portfolio including generics, complex generics, specialty medicines, and biosimilars. Lupin maintains a strong leadership position in the U.S. and India, focusing on therapeutic areas such as cardiovascular, respiratory, diabetes, gastrointestinal, and women’s health. The company operates 15 state-of-the-art manufacturing facilities and 6 research centers, employing over 26,000 professionals worldwide.
Source: BSE
